Cleared Traditional

K162218 - Pain Freeze™, Medium Stream Spray, Model #2101 (FDA 510(k) Clearance)

Also includes:
Pain Freeze™, Mist Spray, Model #2102
K162218 · Nuance Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
106d
Days
-
Risk

K162218 is an FDA 510(k) clearance for the Pain Freeze™, Medium Stream Spray, Model #2101. Classified as Vapocoolant Device (product code MLY).

Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K162218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date November 22, 2016
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -